| Supplier qualification | Require documented quality, environmental, change-control, traceability, and business-continuity systems before production approval. | Completed supplier questionnaire, process map, audit report, capacity statement, organization chart, and corrective-action history. | All critical findings closed or assigned with an approved due date before production release. | Initial qualification; annual review; reassessment after major process or ownership changes. | Hidden process weaknesses, uncontrolled subcontracting, and delayed corrective action. |
| RoHS compliance | Supplier shall comply with Directive 2011/65/EU and applicable amendments, including the ten restricted substances and applicable maximum concentration values. | Current supplier declaration, material declarations, component-level evidence, exemption references where applicable, and test reports for risk-based verification. | Every supplied part, finish, solder, cable, adhesive, and packaging material is covered by a valid declaration or approved exemption. | At onboarding; on material change; on regulatory update; at least annually for active products. | Market-access restrictions, customs delays, product recall, or customer nonconformance. |
| REACH obligations | Supplier shall identify substances of very high concern in articles and notify the buyer when the concentration exceeds 0.1% weight by weight, where applicable. | REACH declaration, material composition data, substance name and concentration range, safety information, and confirmation of relevant Candidate List screening. | No undisclosed reportable substance; required information supplied within the contract notification period. | At onboarding; whenever the Candidate List changes; after formulation or material changes. | Incomplete legal disclosures, customer notification failures, and restricted-market exposure. |
| Engineering change control | No change to component source, PCB laminate, finish, solder paste, assembly site, equipment, process parameter, or subcontractor without written approval. | Change notice, reason and impact assessment, affected part numbers, qualification plan, implementation date, and updated compliance records. | Buyer approval received before shipment of changed product; obsolete and revised records remain traceable. | Per change; quarterly review of open and recently implemented changes. | Unapproved substitutions, field failures, and loss of configuration control. |
| PPAP submission | Require a risk-based Production Part Approval Process submission before mass production and after defined changes. | Design records, approved change documents, process flow, PFMEA, control plan, measurement-system evidence, dimensional results, material certificates, capability data, sample parts, and submission warrant. | Submission level specified by the buyer; all critical and significant characteristics addressed; unresolved deviations formally approved. | Before production release; after tooling, site, process, material, or supplier changes. | Production starts without objective evidence that the process can meet requirements. |
| Process capability | Define capability targets for critical characteristics and require an approved reaction plan for out-of-control or out-of-specification conditions. | Control charts, capability studies, inspection results, measurement-system analysis, defect Pareto, and corrective-action records. | Target values and sampling plan agreed per product risk; capability results meet the contract or have written deviation approval. | Launch, first-article approval, process drift, and periodic production review. | Intermittent solder, placement, cleanliness, or electrical defects reaching final inspection. |
| PCB assembly workmanship | Specify the applicable assembly workmanship, soldering, cleanliness, inspection, and acceptance requirements in the drawing or quality agreement. | Inspection criteria, first-article report, automated optical inspection data, X-ray results where required, electrical test records, and rework log. | All critical defects rejected; workmanship class and acceptance limits documented before quotation and production. | Every production lot; additional review after process or design changes. | Latent reliability failures, unrepeatable inspection decisions, and warranty exposure. |
| Traceability | Maintain lot-level or serial-level traceability from bare PCB and components through assembly, inspection, test, shipment, and rework. | Lot numbers, date codes, feeder or machine records, operator and equipment identifiers, inspection results, test records, and shipment linkage. | Affected units can be identified within one business day using retained electronic records. | Every lot; record-retention period defined by product risk and applicable law. | Broad and costly containment actions when a component or process defect is found. |
| Counterfeit and obsolete-part prevention | Limit purchasing to approved channels and require authorization for independent distributors, reclaimed parts, substitutions, or date-code exceptions. | Approved-vendor list, certificates of conformance, visual inspection, electrical verification, chain-of-custody records, and authenticity test results where risk warrants. | No unauthorized source or substitution; high-risk parts receive enhanced verification before use. | Per purchase order; quarterly review for allocation, shortage, and end-of-life parts. | Early failure, nonconforming performance, and inability to reproduce supply history. |
| Dual-source resilience | Identify single-source dependencies and maintain an approved second source for critical components, bare boards, and assembly capacity where technically and commercially feasible. | Source-risk register, approved alternate list, qualification status, capacity data, lead-time data, geographic exposure, and transfer plan. | Critical items have an approved alternate or a documented mitigation with owner and completion date. | Monthly for critical shortages; quarterly for the complete risk register. | Line stoppage caused by allocation, regional disruption, insolvency, disaster, or capacity loss. |
| Second-source qualification | Require form, fit, function, compliance, reliability, and process equivalence before an alternate source is released for production. | Gap analysis, samples, dimensional results, electrical test results, reliability evidence, compliance declarations, and updated PPAP package. | All differences assessed; product and process approval completed before routine use. | At alternate-source approval; revalidation after significant change. | A nominal second source that cannot actually produce interchangeable, compliant product. |
| Capacity and continuity planning | Define forecast visibility, minimum capacity reservation, recovery-time expectations, inventory responsibilities, and emergency communication procedures. | Capacity model, bottleneck analysis, business-continuity plan, disaster-recovery test results, recovery assumptions, and escalation contacts. | Capacity supports the agreed demand scenario; recovery actions and communication times are demonstrated and current. | Monthly forecast review; annual continuity exercise; immediate review after a major incident. | Unplanned backlog, extended customer lead times, and ineffective crisis response. |
| Supplier performance scorecard | Set measurable service, quality, delivery, compliance, and responsiveness targets with escalation thresholds. | On-time delivery, defect rate, corrective-action closure, change-notice compliance, responsiveness, and shortage metrics. | Targets and weighting agreed before award; repeated misses trigger corrective action, audit, or source-transfer review. | Monthly operational review; quarterly business review. | Problems remain anecdotal and procurement decisions lack objective evidence. |
| Commercial protection | Define tooling ownership, material liability, forecast obligations, price-review rules, lead-time commitments, warranty, and exit or transfer assistance. | Signed quality agreement, statement of work, approved pricing schedule, tooling register, inventory report, and transition plan. | Responsibilities are unambiguous; buyer-owned assets and production records are recoverable on request or termination. | At contract award; annual commercial review; before renewal or transfer. | Unexpected cost, stranded inventory, delayed transfer, and dependence on one supplier. |